--- title: Clinical trials involving Medical Devices and Medicinal Products. How can we manage regulatory assessments? description: Learn how to manage regulatory assessments for clinical trials for medical devices and medicinal products. Understand different scenarios and requirements. image: https://blog.pqegroup.com/hubfs/Clinical%20Trials%20MD%20MP_Site%20Banner.jpg --- [![Logo PQE Group - azzurro - 2024](https://blog.pqegroup.com/hs-fs/hubfs/Logo%20PQE%20Group%20-%20azzurro%20-%202024.png?width=2000&height=721&name=Logo%20PQE%20Group%20-%20azzurro%20-%202024.png "Logo PQE Group - azzurro - 2024")](https://www2.pqegroup.com) - [Home](https://www2.pqegroup.com/) - [Industry](https://www2.pqegroup.com/industry/) - [Pharma & API](https://www2.pqegroup.com/pharma-api/) - [Medical Device](https://www2.pqegroup.com/medical-device/) - [Biotech](https://www2.pqegroup.com/biotech/) - [Startup](https://www2.pqegroup.com/startup/) - [Veterinary](https://www2.pqegroup.com/veterinary/) - [Services](https://www2.pqegroup.com/services/) - [Data Integrity](https://www2.pqegroup.com/data-integrity/) - [Digital Governance](https://www2.pqegroup.com/digital-governance/) - [Engineering](https://www2.pqegroup.com/engineering/) - [Commissioning, Qualification and Validation (CQV)](https://www2.pqegroup.com/commissioning-qualification-validation/) - [Quality Compliance](https://www2.pqegroup.com/quality-compliance/) - [Laboratory Excellence](https://www2.pqegroup.com/laboratory-excellence/) - [Regulatory Affairs](https://www2.pqegroup.com/regulatory-affairs/) - [Audits](https://www2.pqegroup.com/audits/) - [Training](https://www2.pqegroup.com/training/) - [Clinical Research](https://www2.pqegroup.com/clinical-research-services/) - [Pharmacovigilance](https://www2.pqegroup.com/pharmacovigilance/) - About - [About Us](https://www2.pqegroup.com/about/) - [ESG](https://www2.pqegroup.com/about/csr/) - [Women in STEM](https://www2.pqegroup.com/about/women-in-stem/) - Resources - [News & Press](https://www2.pqegroup.com/news/) - [Webinars](https://www2.pqegroup.com/webinars/) - [Blog](https://blog.pqegroup.com/) - [Careers](https://www2.pqegroup.com/careers/) - [Contact Us](https://www2.pqegroup.com/contact-us/) ![PQE Group](https://blog.pqegroup.com/hubfs/PQE%20Group%20logo%202024%20white%20background.png) PQE Group By: PQE Group # **Clinical trials involving Medical Devices and Medicinal Products. How can we manage regulatory assessments?** [Medical Device](https://blog.pqegroup.com/tag/medical-device) Medicinal product clinical trials involving medical devices might be summarized in the following three cases:  1. The object of the study is one integral product which is a 'combination' of a medical device and a medicinal product, e.g., a pre-filled insulin syringe.  Products that administer a drug shall be regulated as medicinal products where the device and the medicinal product form a Single Integral Product (including co-packaged and referenced). These products are covered by Medicines Legislation (**Directive 2001/83/EC**), although in addition to this, the relevant **GSPR in Annex 1 of the MDR 2017/745** applies to the medical device.   An exception is seen in the following situation:   - Devices incorporating, as an integral part, a substance, which, if used separately, may be considered to be a medicinal product, subject to the **Medical Device Regulation 2017/745/EEC**.  For Case 1, the medicinal product dossier should include a discussion of the impact of the device on the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQA) and overall control strategy of the medicinal product.  If the device has a CE marking, then the applicant must provide a Declaration of Conformity or, where applicable, an EU Certificate issued by a Notified Body designated for the type of device in question, allowing the manufacturer to affix the CE marking to the device.  If the device does not hold a CE marking and the dossier does not include a Declaration of Conformity or where applicable, an EU Certificate issued by a Notified Body designated, then the applicant must provide an opinion from a Notified Body on the conformity of the device with the relevant general safety and performance requirements set out in **Annex I to Regulation (EU) 2017/745**.  **2.** The object of the study is a medicinal product but during the clinical trial medical devices are used, e.g., a Companion Diagnostic device.  In this case, two scenarios are allowed for the MD/IVD in subject:  a. The device is CE marked, complying with the EU-rules for placing on the market and putting into service of medical devices Article 5 MDR EU/745/2017;  b. The device is not CE marked. Then two possible options are available: i. Article 5(5) MDR EU/745/2017 is applicable; ii. Article 5(5) is not applicable. In this case the applicant must have the CE marking for the medical device.  **3.** The objects of the study are two separate products: one is a medicinal product and one is a medical device.  a. For the aspects of the study having as object the medicinal product, Directive 2001/20/EC as replaced by REGULATION (EU) No 536/2014 is applied. b. Regarding the medical device being the object of the study, Regulation EU/745/2017 is applied (Art. 62-80, Art. 82 and Annex XV).  ![Clinical Trials MD MP_Site Banner](https://blog.pqegroup.com/hs-fs/hubfs/Clinical%20Trials%20MD%20MP_Site%20Banner.jpg?width=2000&name=Clinical%20Trials%20MD%20MP_Site%20Banner.jpg) ## More on the Regulatory scope for Medical Devices? One of PQE Group's unique features, is its global presence, with a dedicated local touch. We'll support you at 'home', providing your business with a rich experience from all over the world. 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